Course catalogue doctoral education - VT20

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Title Gene and Cell Therapy Product (ATMP) Drug Development
Course number 3218
Programme 1-Ingår i flera program
Language English
Credits 1.5
Date 2020-03-30 -- 2020-04-03
Responsible KI department Institutionen för klinisk vetenskap, intervention och teknik
Specific entry requirements
Purpose of the course In this course, the students acquire an understanding of how to develop a gene or cell therapy product (ATMP), including Good Manufacturing Practice (GMP) production and proving efficacy through clinical trials. The course provides a broad understanding of ATMP development from a research idea to registration as an approved form of therapy where the cost of treatment is covered by the state. Students will learn about the European Medicines Agency (EMA) regulations for ATMP and requirements for commercial models and health economy considerations. This broad scope gives students access to information and contacts for a plethora of future career opportunities in ATMP development and provides an opportunity to build both national and international networks.
Intended learning outcomes After the completed course, the doctoral student can:
- fully understand and review the classification of ATMPs and the regulations associated with different stages of the ATMP development pipeline.
- understand and critically review the research, development, manufacture, clinical, and commercial aspects of ATMP.
- understand and review the need for multi-disciplinary expertise and interactions for translation of research with commercial and clinical considerations.
Contents of the course To achieve a better understanding of ATMP development, and to construct systems and organisations for bringing ATMP options to patients, it is necessary to understand the specific needs in terms of research, commercial and clinical aspects. In this course, leading experts in the fields of ATMP drug development will discuss different aspects of intellectual property, regulation, manufacture, clinical trials, health economy, business models and marketing approval strategy in general and more specifically using various ATMPs as examples. The nature of the course is translational and provides a wide range of knowledge from pre-clinical to GxP to patient delivery and market approval.
Teaching and learning activities The course is a combination of theoretical knowledge and practical skills. Some of the lecture parts of the course are based around a sandwiched conference on the same theme. There are additional lectures on basic knowledge of the field as well as practical activities and demonstrations such as some basic GMP philisophy and procedures. The course is demanding and requires full-time presence and attention.
Compulsory elements Full presence in all parts of the course is required. Necessary absence will be regulated with the course leader and compensated as extra tasks.
Examination The students are examined with an individual written report according to the course learning outcomes. The participants receive written feedback for their reports from the examiner. All students are also required to peer-review another student's examination report.
Literature and other teaching material Recommended literature: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/advanced-therapies/advanced-therapy-classification
https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Produktomraden/Avancerade-terapier/
atmpsweden.se
Number of students 8 - 16
Selection of students Selection will be based on 1) the relevance of the course syllabus for the applicant's doctoral project (according to written motivation), 2) start date of doctoral studies (priority given to earlier start date).
More information The course is full time. This course represents a national cooperation in ATMP education in large part through co-operation with the Centre for Advanced Medical Products (CAMP) and Swelife-ATMP. It is given jointly by the doctoral programmes Cell Biology and Genetics (CBG) and Development and Regeneration (DEVREG). See: https://ki.se/en/staff/doctoral-programmes.
Additional course leader
Latest course evaluation Not available
Course responsible Heather Main
Institutionen för klinisk vetenskap, intervention och teknik

heather.main@ki.se
Contact person Heather Main
Institutionen för klinisk vetenskap, intervention och teknik

heather.main@ki.se